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Purpose

This extension study is being conducted to assess the following objectives through 12 months post-cardiac surgery: - Patient reported outcomes (PRO), using the EQ-5D questionnaire - Clinical outcomes

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Subjects must have completed the REN-007 study to be eligible to participate in the Extension Study.

Exclusion Criteria

  • Subjects who did not complete the REN-007 study are not eligible to participate in the Extension Study. - Female subjects who become pregnant during the REN-007 study are not eligible to participate in the Extension Study.

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
RBT-1 Patients undergoing CABG, valve, or combined CABG/valve surgery
  • Drug: RBT-1
    Intravenous administration
Placebo Patients undergoing CABG, valve, or combined CABG/valve surgery
  • Drug: Placebo
    Intravenous administration

Recruiting Locations

More Details

NCT ID
NCT06092970
Status
Active, not recruiting
Sponsor
Renibus Therapeutics, Inc.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.

For help using this page: trialstoday@researchmatch.org or call 855-514-7001

ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

Vanderbilt University Medical Center